MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-25 for GRIP-LOK 3300M manufactured by Tidi Products Llc.
[121638174]
Eval: since the product was not returned for evaluation, the reported issue could not be confirmed. This report is being submitted solely on the reported issue. If the line becomes stuck to the device when attempting to replace the device, unintended line removal or interruption of patient treatment is likely. This report is being submitted as a result of a remediation capa to reassess product risks. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[121638175]
Customer reported when the device is removed from the lines, the adhesive separates from the top velcro tab and the line is stuck in the device. The issue was reported on (b)(4) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00008 |
| MDR Report Key | 7906666 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-13 |
| Date of Event | 2016-09-09 |
| Date Mfgr Received | 2018-09-13 |
| Date Added to Maude | 2018-09-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JACKIE KRIEGLSTEIN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRIP-LOK |
| Generic Name | GRIP-LOK MEDIUM STERILE |
| Product Code | KMK |
| Date Received | 2018-09-25 |
| Model Number | 3300M |
| Catalog Number | 3300M |
| Lot Number | 23249833 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS LLC |
| Manufacturer Address | 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-25 |